Neural Basis of Social Cognition Deficits
Recruiting · NCT05185128 · Interventional (participants receive a specific treatment) · Lead sponsor: Loma Linda University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Difficulties in reciprocal social interaction are hallmark features of several neuropsychiatric disorders, most notably autism spectrum disorder (ASD) and schizophrenia spectrum disorder (SSD). While recent studies have demonstrated substantial overlap in genetic etiology between ASD and SSD, little is known about common versus unique neural mechanisms that may underlie these downstream social deficits that cross diagnostic boundaries. Thus, a comprehensive imaging study examining social deficits in youth with ASD and adolescent- onset SSD at the neurochemical, connectivity, as well as functional activation level will be crucial in furthering our understanding of these underlying neural mechanisms. Specifically, the current project aims to examine how targeted social skills interventions may impact the organization of large-scale functional brain networks implicated in social cognition in these disorders, leading to improved outcomes. Thirty adolescents with ASD and 30 adolescents with SSD will undergo the Program for the Education and Enrichment of Relational Skills (PEERS), which is a 16-week parent-assisted social skills intervention that aims to improve friendship quality and social skills in teens with social difficulties. All participants will receive pre- and post-treatment MRI scans including functional MRI and magnetic resonance spectroscopy to quantify neural changes resulting from the intervention. All participants will also receive behavioral and social cognition assessments pre- and post-intervention to quantify real- world gains in social behaviors resulting from the intervention. Additionally, 30 typically developing adolescents will be recruited to serve as control participants and undergo two MRI and behavioral assessment sessions 16-weeks apart with no intervention in between. Specific aims include (1) examining inter-group disruptions in connectivity patterns, activation levels, and neurometabolite concentrations in key social brain regions pre-treatment in ASD and SSD groups, (2) examining inter-group changes in connectivity patterns, activation levels, and neurometabolite concentrations in key social brain regions in response to treatment in ASD and SSD groups, and, (3) dimensionally identifying intra-group differences in brain responses and how they relate to real-world treatment outcomes.
Who can take part
Inclusion criteria
- Participants in this study will be 30 ASD adolescents and 30 demographically matched adolescents with SSD who undergo the PEERS social skills training program. Participants will be between the ages of 12-18 years, and mostly male reflecting the higher prevalence in the population of ASD, and to a lesser extent, SSD. The ASD adolescents will be recruited through the Loma Linda University Behavioral Health Institute (LLU BHI), LLU Behavior Medicine Center (BMC), and LLU Department of Psychology Child and Family Center (CFC). The SSD adolescents will be recruited from the BMC inpatient, partial hospitalization, intensive outpatient, and standard outpatient programs for youth with psychosis. Thirty demographically comparable typically developing (TD) controls will be recruited through community samples, and in compliance with the LLU Institutional Review Board (IRB) standards. Before enrolling in the proposed MRI studies, prospective ASD participants will undergo testing with experienced assessors. Clinical diagnosis will be confirmed using both the Autism Diagnostic Interview- Revised, and the Autism Diagnostic Observation Schedule, 2nd edition. SSD participants will be screened using the Structured Clinical Interview for DSM-IV (SCID) Axis I diagnoses, with additional modules for assessment of childhood disorders. SSD participants must meet criteria for schizophrenia, schizophreniform, schizoaffective disorder, or unspecified schizophrenia spectrum and other psychotic disorder. All study participants will have verbal IQ as well as Full Scale IQ of 70 or higher on the Wechsler Abbreviated Scale of Intelligence (WASI-II) to ensure they will have the language and cognitive ability to participate in an MRI scan.
Exclusion criteria
- Exclusion criteria will include history of significant medical/neurologic conditions that would affect neuroimaging interpretation (e.g., epilepsy, tumor), and any psychiatric history for TD controls. Participants with any MRI contraindications (e.g., history of metal fragment injury or metal implants, current orthodontic braces or nonremovable retainers) will also be excluded in compliance with scanner safety standards.
Where it is running
1 location listed across 1 US state.
- Loma Linda U - Loma Linda, California, United States